Patient leaflet - Dosulepin Hydrochloride 25 mg capsules

1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR

The name of your medicine is Dosulepin Hydrochloride 25mg Capsules (called Dosulepin in the rest of this leaflet). The active ingredient in is dosulepin hydrochloride. Dosulepin belongs to a group of medicines called antidepressants.

Dosulepin is used to treat depression and can also help reduce feelings of anxiety. Please ask your doctor or pharmacist if you need more information.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOSULEPIN

Do not take dosulepin capsules if:

You are allergic to dosulepin or any of the other ingredients in this medicine (see Section 6).
You have the eye condition known as glaucoma.
You are pregnant or planning to become pregnant or are breast feeding.
You have an irregular heartbeat, recent heart attack or any other heart problem.
You have severe liver problems.
If you have been diagnosed as having mania (feeling over-excited accompanied by unusual behaviour).You are a child or adolescent under the age of 18 years.
You are taking any of the following medicines:
- A mono-amine oxidase inhibitor (MAOI), used to treat depression. You should not take dosulepin with MAOI’s or within 14 days of stopping them.
- Any hay fever/allergy treatment which contains terfenadine or astemizole.
- Sotolol (for heart or blood pressure problems) or halofantrine (for malaria).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dosulepin if

You have difficulty in passing urine or have prostate problems
You have epilepsy (suffer from convulsions or fits) e.g. phenytoin, primidone, carbamazepine
You have a thyroid problem
You have a tumor of the adrenal gland ( a gland above the kidney)
You are diabetic, as your blood sugar levels may change whilst taking dosulepin
You are receiving electro-shock therapy (ECT) (used in severe depression)
You suffer from porphyria (a disease causing damage to nerves and skin sensitivity)
You have a history of mania or psychoses
You have cardiac disease
You have severe renal disease
You suffer from hyperthyroidism

The elderly are at higher risk of experiencing side effects while taking this medicine, especially agitation, confusion and lightheadedness.

Tell your surgeon or dentist that you are taking Dosulepin if surgery is planned. It may affect the anaesthetic used.

A risk of suicide, self-harm and hostility cannot be excluded with Dosulepin.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased with first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this:

If you previously had thoughts about killing or harming yourself.
If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and to ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Other medicines and dosulepin

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines including any obtained without a prescription.

It is particularly important to tell your doctor or pharmacist if you are taking any of the following medicines as these may affect the safe and effective use of Dosulepin:

A type of medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). You should not take Dosulepin capsules while taking these or within 14 days of stopping them. E.g. selegiline, rasagiline
Other types of medicines used to treat depression called SSRIs (selective serotonin reuptake inhibitors).
Any medicines given to you for treating high blood pressure (hypertension) e.g. betanidine, debrisoquine, guanethidine, clonidine
Medicines used in heart conduction disorders, e.g. quinidine, amiodarone, flecainide, procainamide, propafenone or disopyramide.
Sotolol, quinidine, Cisapride, pentamidine isethionate, clonidine (a medicine used for heart or blood pressure problems)
Halofantrine (a medicine for malaria)
Rifampicin (an antibacterial)
Any hayfever or allergy medicine containing terfenadine or astemizole.
Any thyroid medication such as Levothyroxine (thyroxine).
Any medication used to treat epilepsy (convulsions or fits).
Any barbiturate (e.g. phenobarbitone used to treat epilepsy, amylobarbitone for insomnia)
Methylphenidate (used to treat certain behavioural problems).
Any medicine containing an opioid/narcotic analgesics. (These include codeine, morphine, dihydrocodeine, coproxamol and co-dydramol).
Tramadol, a strong pain-killer
Medicines called sympathomimetic agents - these include ephedrine, pseudoephedrine, adrenaline and noradrenaline. (These may be found in medicines used to treat heart problems and asthma as well as some decongestants and cough/cold remedies). This list contains medicines that are prescribed by a doctor and also some that you can buy
from your pharmacist.
Medicines called antimuscarinics(medicines for Parkinson’s disease, stomach and bladder problems)
Pimozide and sertindole (medicines for serious mental problems)
Cimetidine (used to treat stomach ulcers)
Diuretic medicines (“water tablets”)
Calcium channel blockers (medicine for heart problems e.g. Amlodipine, diltiazem, nifedipine, verapamil)
Oestrogen-containing contraceptives (these may decrease the antidepressant effect of dosulepin)
Local anaesthetics
Quinolone antibiotics e.g. moxifloxacin
Atomoxetine used to treat Attention-Deficit / Hyperactivity Disorder (ADHD)
Warfarin, coumarin or other anticoagulants, as there could be changes in bleeding times
Ritonavir used in the treatment of HIV.

Dosulepin with food, drink and alcohol

Drinking alcohol with dosulepin can make the feeling of drowsiness worse.

Pregnancy, breast feeding and fertility

You should not take dosulepin if you are pregnant or breastfeeding. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Patients should be advised that withdrawal of this medicine should be gradual. If you stop taking this medicine suddenly you may experience some withdrawal symptoms including insomnia, irritability and excessive perspiration. Similar symptoms may occur in newborn babies whose mothers have received this medicine during the last 3 months of pregnancy.

Driving and using machines

Dosulepin can make you feel drowsy. Do not drive, operate machinery or do anything that requires you to be alert until you know how the capsules affect you. Feeling drowsy in the day can improve with time, but if drowsiness becomes a problem, you should tell your doctor. If you drink alcohol with these capsules it can make the feeling of drowsiness worse.

Dosulepin contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these Capsules.

3. HOW TO TAKE DOSULEPIN

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosulepin capsules should be swallowed whole with a drink of water. Do not chew them. If you chew the capsule, you may experience a bitter taste and a temporary numbness of your tongue.

It may take two to four weeks of treatment before you begin to see an improvement in your mood. You may, however, notice an earlier improvement in your anxiety symptoms. It is important that you keep taking these capsules until your doctor tells you to stop. Don’t stop just because you feel better. If you stop taking the capsules too soon, your condition may get worse.

The exact number of capsules that you will need to take will be decided by your doctor. Your doctor will also tell you when you should take them. If you need more information, you should ask your doctor or pharmacist. The following are given as guidelines.

Adults: The usual starting dose is 3 capsules a day. Your doctor will tell you whether to take the capsules as separate doses throughout the day or as a single dose each evening. The evening dose is best taken a couple of hours before going to bed. Normally, not more than 9 capsules (equivalent to 225mg dosulepin) should be taken each day.

Elderly: Initially, 2 to 3 capsules a day.

Children: Not recommended.

If you take more dosulepin than you should:

If you have taken more than the stated dose (an overdose), go to the nearest hospital casualty department immediately. Show them the capsules and any other medicines that may have been taken.

Dosulepin may seriously harm you and may be life threatening if you take too many capsules or tablets. You should SEEK IMMEDIATE HELP if a child takes any capsules or tablets or if you or anybody else accidentally takes too many capsules or tablets. Remember to take the pack with you, even if it is empty. The main symptoms of over dose are unconsciousness, convulsions, reduction in heart and lung function and life threatening heart rhythm disorders which may even occur after apparent recovery. Remember to take the pack with you, even if its empty.

If you forget to take dosulepin

If you forget to take a dose, do not worry, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking dosulepin

Do not stop taking dosulepin just because you feel better. Patients should be advised that withdrawal of this medicine should be gradual. If you stop taking this

Medicine suddenly you may experience some withdrawal symptoms including insomnia, headaches, nausea, giddiness, panic-anxiety, restlessness, irritability and excessive perspiration.

If you have any further questions on use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor (or go to a hospital straight away) if you get any of the following serious side effects:

Rare (between 1 and 10 of every 10,000 patients treated):

Bone marrow depression or reduction in some blood cells (you may experience unusual bruising or abnormal bleeding, sore throat and fever, mouth ulcers)
Liver problems with yellowing of the skin and eyes (jaundice)
Hepatitis (damage to the liver causing dark urine, jaundice, nausea and fever)
A fever (high temperature, sweating, shivering)
Discomfort around the right lower rib cage
Severe mood changes such as extreme excitability
Convulsions (fits)
Irregular heartbeat (more likely with high dosage)

Other possible side effects during treatment

Common (between 1 and 10 of every 100 patients) treated:

Dry mouth,
Blurred vision
Changes in the heart beat or heart conduction
Dizziness
Constipation
Increased appetite
Weight gain or weight loss
Sedation
Difficulty in passing urine.

These problems tend to improve with time.

Uncommon (between 1 and 10 of every 1000 patients)

Severe allergic reaction to Dosulepin (you may experience a skin rash, itching, swollen face or tongue, shortness of breath, collapse). If you develop an unexpected skin rash or difficulty breathing stop taking the capsules and contact your doctor.

Severe low blood pressure which may cause dizziness, on standing (postural hypotension).
Increased sweating
Tiredness or sleepiness
Confusion and hallucination (strange vision or sounds)
Tremors or feeling shaky.
Changes in sex drive
Changes in the heartbeat.
An allergic reaction (e.g. skin sensitivity to light, itching, redness)
Changes in levels of sugar and sodium in the blood (seen in blood tests)
Enlargement of the testicles
Swelling of the breasts in men
Milk production in the breasts not related to pregnancy
or breast feeding
Impairment of movement
Abnormal body movements
Delusions (abnormal thoughts)
Nervousness
Seizures
Speech difficulties
Raised blood pressure
Nausea and vomiting
Weakness

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

An increased risk of bone fractures has been observed in patients taking these types of medicines.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DOSULEPIN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP." The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND FURTHER INFORMATION

What dosulepin Capsules contains

The active substance is dosulepin hydrochloride. Each capsule contains dosulepin hydrochloride 25mg
The other ingredients are lactose monohydrate, maize starch, magnesium stearate.
In addition, following are the contents of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172).

What Dosulepin Looks Like and Contents of the Pack

Dosulepin 25mg capsules are hard gelatin capsule size “4” with brown opaque body and reddish-brown opaque cap containing white to off white powder.

Dosulepin 25mg capsules is available in Alu/PVC/PVDC blister packs of 28 capsules . Not all pack sizes may be marketed.

Marketing Authorisation Holder

Crescent Pharma Limited

Key House, Sarum Hill,

Basingstoke, RG21 8SR

United Kingdom

Telephone: 01256 772 730

Email: Safety@crescentpharma.comManufacturer:

Mobius Laboratories Limited Unit 7, Bourne End Mills Upper Bourne End Lane Hemel Hempstead Hertfordshire

HP1 2UJ